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46 device results listed.

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EurobioPlex Streptocoque Groupe B (SGB/Streptococcus agalactiae)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Eurobio Scientific
Manufacturer SRN: FR-MF-000011745
UDI-DI: D-EBX-039-25DN
Basic UDI-DI: B-EBX-039-25DN
Reference: EBX-039-25
EMDN: W0105011299
EMDN description: STAPHYLOCOCCI REAGENTS - OTHER
First on market country: France
Authorised representative: -
Last updated: 31.07.2026 22:47

Manufacturer products View details

EurobioPlex Streptocoque Groupe B (SGB/Streptococcus agalactiae)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Eurobio Scientific
Manufacturer SRN: FR-MF-000011745
UDI-DI: D-EBX-039-10049
Basic UDI-DI: B-EBX-039-10049
Reference: EBX-039-100
EMDN: W0105011299
EMDN description: STAPHYLOCOCCI REAGENTS - OTHER
First on market country: France
Authorised representative: -
Last updated: 31.07.2026 22:47

Manufacturer products View details

EurobioPlex Streptocoque Groupe B (SGB/Streptococcus agalactiae)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Eurobio Scientific
Manufacturer SRN: FR-MF-000011745
UDI-DI: D-EBX-039-50DM
Basic UDI-DI: B-EBX-039-50DM
Reference: EBX-039-50
EMDN: W0105011299
EMDN description: STAPHYLOCOCCI REAGENTS - OTHER
First on market country: France
Authorised representative: -
Last updated: 31.07.2026 22:47

Manufacturer products View details

01220000260221

NATtrol™ Chlamydia trachomatis Positive Control Pack

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testing

Manufacturer: ZeptoMetrix LLC
Manufacturer SRN: US-MF-000035245
UDI-DI: 01220000260221
Basic UDI-DI: 122000026NATERCK5
Reference: NATMSSA-6MC-IVD
EMDN: W0105011203
EMDN description: SAPHYLOCOCCAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 17.07.2026 08:27

Manufacturer products Authorised representative products Authorised representative actors View details

01220000260214

NATtrol™ Chlamydia trachomatis Positive Control Pack

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testing

Manufacturer: ZeptoMetrix LLC
Manufacturer SRN: US-MF-000035245
UDI-DI: 01220000260214
Basic UDI-DI: 122000026NATERCK5
Reference: NATMSSE-6MC-IVD
EMDN: W0105011203
EMDN description: SAPHYLOCOCCAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 17.07.2026 08:20

Manufacturer products Authorised representative products Authorised representative actors View details

01220000260207

NATtrol™ Chlamydia trachomatis Positive Control Pack

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testing

Manufacturer: ZeptoMetrix LLC
Manufacturer SRN: US-MF-000035245
UDI-DI: 01220000260207
Basic UDI-DI: 122000026NATERCK5
Reference: NATMRSA-6MC-IVD
EMDN: W0105011203
EMDN description: SAPHYLOCOCCAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 17.07.2026 08:14

Manufacturer products Authorised representative products Authorised representative actors View details

50604724675466

Rabbit Coagulase Plasma

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Pro-Lab Diagnostics UK
Manufacturer SRN: GB-MF-000003833
UDI-DI: 50604724675466
Basic UDI-DI: B-50604724675466
Reference: PL.850-30
EMDN: W0105011203
EMDN description: SAPHYLOCOCCAL DETECTION BY NA REAGENTS
First on market country: Netherlands
Authorised representative: Advena Limited
Last updated: 17.07.2026 02:22

Manufacturer products Authorised representative products Authorised representative actors View details

50604724675398

Rabbit Coagulase Plasma

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Pro-Lab Diagnostics UK
Manufacturer SRN: GB-MF-000003833
UDI-DI: 50604724675398
Basic UDI-DI: B-50604724675398
Reference: PL.850-20
EMDN: W0105011203
EMDN description: SAPHYLOCOCCAL DETECTION BY NA REAGENTS
First on market country: Netherlands
Authorised representative: Advena Limited
Last updated: 17.07.2026 02:22

Manufacturer products Authorised representative products Authorised representative actors View details

50604724675220

Rabbit Coagulase Plasma

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Pro-Lab Diagnostics UK
Manufacturer SRN: GB-MF-000003833
UDI-DI: 50604724675220
Basic UDI-DI: B-50604724675220
Reference: PL.850-10
EMDN: W0105011203
EMDN description: SAPHYLOCOCCAL DETECTION BY NA REAGENTS
First on market country: Netherlands
Authorised representative: Advena Limited
Last updated: 17.07.2026 02:22

Manufacturer products Authorised representative products Authorised representative actors View details

50604724675152

Rabbit Coagulase Plasma

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Pro-Lab Diagnostics UK
Manufacturer SRN: GB-MF-000003833
UDI-DI: 50604724675152
Basic UDI-DI: B-50604724675152
Reference: PL.850-3
EMDN: W0105011203
EMDN description: SAPHYLOCOCCAL DETECTION BY NA REAGENTS
First on market country: Netherlands
Authorised representative: Advena Limited
Last updated: 17.07.2026 02:22

Manufacturer products Authorised representative products Authorised representative actors View details

Xpert®

Xpert® MRSA/SA Blood Culture

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid AB
Manufacturer SRN: SE-MF-000002020
UDI-DI: 07332940007140
Basic UDI-DI: B-07332940007140
Reference: GXMRSA/SABC-CE-10
EMDN: W0105011203
EMDN description: SAPHYLOCOCCAL DETECTION BY NA REAGENTS
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 19:56

Manufacturer products View details

Xpert®

Xpert® MRSA /SA SSTI

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid AB
Manufacturer SRN: SE-MF-000002020
UDI-DI: 07332940002473
Basic UDI-DI: B-07332940002473
Reference: GXMRSA/SA-SSTI-CE
EMDN: W0105011203
EMDN description: SAPHYLOCOCCAL DETECTION BY NA REAGENTS
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 19:55

Manufacturer products View details

Xpert®

Xpert® SA Nasal Complete

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid AB
Manufacturer SRN: SE-MF-000002020
UDI-DI: 07332940001889
Basic UDI-DI: B-07332940001889
Reference: GXSACOMP-CE-10
EMDN: W0105011203
EMDN description: SAPHYLOCOCCAL DETECTION BY NA REAGENTS
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 19:55

Manufacturer products View details

BBL STAPHYLOSLIDE

BD BBL™ Staphyloslide™ Latex Test Kit

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Becton, Dickinson and Company
Manufacturer SRN: US-MF-000018910
UDI-DI: 00382902409151
Basic UDI-DI: 038290QUHMNYFQML
Reference: 240915
EMDN: W0105011299
EMDN description: STAPHYLOCOCCI REAGENTS - OTHER
First on market country: Belgium
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 15.07.2026 23:42

Manufacturer products Authorised representative products Authorised representative actors View details

GenomEra MRSA/SA AC Assay Kit

CDX-30-05

IVD generalIVDDNo longer on the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Uniogen Oy
Manufacturer SRN: FI-MF-000032341
UDI-DI: D-CDX-30-05-40UPS
Basic UDI-DI: B-CDX-30-05-40UPS
Reference: CDX-30-05-40
EMDN: W0105011203
EMDN description: SAPHYLOCOCCAL DETECTION BY NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 04:00

Manufacturer products View details

GenomEra® MRSA/SA AC Assay Kit

CDX-30-05

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Abacus Diagnostica Oy
Manufacturer SRN: FI-MF-000024114
UDI-DI: D-CDX-30-05-40UE
Basic UDI-DI: B-CDX-30-05-40UE
Reference: CDX-30-05-40
EMDN: W0105011203
EMDN description: SAPHYLOCOCCAL DETECTION BY NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 04:00

Manufacturer products View details

GenomEra MRSA/SA AC Assay Kit

CDX-30-05

IVD generalIVDDNo longer on the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Uniogen Oy
Manufacturer SRN: FI-MF-000032341
UDI-DI: D-CDX-30-05-20UPG
Basic UDI-DI: B-CDX-30-05-20UPG
Reference: CDX-30-05-20
EMDN: W0105011203
EMDN description: SAPHYLOCOCCAL DETECTION BY NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 03:59

Manufacturer products View details

GenomEra® MRSA/SA AC Assay Kit

CDX-30-05

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Abacus Diagnostica Oy
Manufacturer SRN: FI-MF-000024114
UDI-DI: D-CDX-30-05-20U8
Basic UDI-DI: B-CDX-30-05-20U8
Reference: CDX-30-05-20
EMDN: W0105011203
EMDN description: SAPHYLOCOCCAL DETECTION BY NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 03:59

Manufacturer products View details

GenomEra MRSA/SA Multi Swab Assay Kit

CDX-30-02

IVD generalIVDDNo longer on the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Uniogen Oy
Manufacturer SRN: FI-MF-000032341
UDI-DI: D-CDX-30-02-20UNF
Basic UDI-DI: B-CDX-30-02-20UNF
Reference: CDX-30-02-20
EMDN: W0105011203
EMDN description: SAPHYLOCOCCAL DETECTION BY NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 03:59

Manufacturer products View details

GenomEra® MRSA/SA Multi Swab Assay Kit

CDX-30-02

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Abacus Diagnostica Oy
Manufacturer SRN: FI-MF-000024114
UDI-DI: D-CDX-30-02-20TK
Basic UDI-DI: B-CDX-30-02-20TK
Reference: CDX-30-02-20
EMDN: W0105011203
EMDN description: SAPHYLOCOCCAL DETECTION BY NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 03:59

Manufacturer products View details